Recent clinical studies have indicated that young women using oral contraceptives may increase their risk of developing breast and cervical cancers in mid-life. These studies have caused anxiety in many women.
Whether this type of contraception is dangerous or not will be the subject of debates for many years to come. One fact was certain, however, the "pill" did interfere with the hormonal balance of the user. Side effects from the use of oral contraceptives have been observed in many women.
Attempts to find safer contraceptive methods have been under study. Recently, a 24-hour vaginal contraceptive sponge has been commercially marketed. The device comprised a polyurethane disc having a central recess and containing 1,000 milligrams of a spermicide known as nonoxynol-9, which was more generically known as nonylphenoxypoly (ethyleneoxy) ethanol.
This type of contraceptive is statistically comparable to the effectiveness reported for that of a diaphragm and prevents pregenancy in three basic ways:
(1)The nonylphenoxypoly (ethyleneoxy) ethanol kills the sperm; PA1 (2) The sponge blocks the cervix and prevents sperm penetration of the uterus; and PA1 (3) The sponge traps and absorbs the sperm. PA1 (a) The spermicide was often diluted, and application of a uniform amount of active spermicide is often unpredictable depending upon the amount of water run through the sponge; PA1 (b) The tap water contained bacteria that destroyed or impaired the sterility of the sponge; PA1 (c) The water contained chemicals, such as chlorine and flourides, that possibly interfered and reacted with the substances contained in the sponge; and PA1 (d) The sponge could not be immediately inserted or used after removal from its package, i.e., the sponge did not contain active spermicide.
While the sponge has met with some success in the market place, its usage has been accompanied by drawbacks. Use of this device required that the spermicide be activated by adding tap water. The mandate for such procedure presented numerous disadvantages:
In addition, the use of 1,000 milligrams of nonoxynol-9 is believed to be excessive, and may cause irritation and allergic reactions.
The sponge-type contraceptive of the present invention is designated to eliminate or substantially reduce all of the aforementioned disadvantages. The contraceptive is packaged in a sealed, bacteria-free, foil packet. Its spermicide is already activated and carried in a solution of distilled water so that the sponge can be immediately used upon removal from its packet. With this procedure, the spermicide of the present invention remains sterile, its dosage is reliable, uniform and effective.
The contraceptive system of the invention contains no greater than approximately 100 milligrams of spermicide, so that optimal spermicidal action is achieved while minimizing the possibility of irritation to the vaginal vault.
Other important innovations of the present invention will be described hereinafter.